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Background Patient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition. Methods Protocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs. Results Eighty-four trials met the inclusion criteria, only 14 (17%) ( n  = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies. Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified. Conclusions Greater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.

Background Precisely defining the different applications of patient-reported outcome measures (PROs) in clinical practice can be difficult. This is because the intervention is complex and varies amongst different studies in terms of the type of PRO used, how the PRO is fed back, and to whom it is fed back. Methods A theory-driven approach is used to describe six different applications of PROs in clinical practice. The evidence for the impact of these applications on the process and outcomes of care are summarised. Possible explanations for the limited impact of PROs on patient management are then discussed and directions for future research are highlighted. Results The applications of PROs in clinical practice include screening tools, monitoring tools, as a method of promoting patient-centred care, as a decision aid, as a method of facilitating communication amongst multidisciplinary teams (MDTs), and as a means of monitoring the quality of patient care. Evidence from randomised controlled trials suggests that the use of PROs in clinical practice is valuable in improving the discussion and detection of HRQoL problems but has less of an impact on how clinicians manage patient problems or on subsequent patient outcomes. Many of the reasons for this may lie in the ways in which PROs fit (or do not fit) into the routine ways in which patients and clinicians communicate with each other, how clinicians make decisions, and how healthcare as a whole is organised. Conclusions Future research needs to identify ways in with PROs can be better incorporated into the routine care of patients by combining qualitative and quantitative methods and adopting appropriate trial designs.

Implementation of patient-reported outcome measures (PROMs) in clinical practice is challenging. We believe effective communication is key to realizing the clinical benefits of PROMs. Communication processes for PROMs in clinical practice typically involve (1) health care professionals (HCPs) inviting patients to complete PROMs, (2) patients completing PROMs, (3) HCPs and patients interpreting the resulting patient-reported outcomes (PROs), and (4) HCPs and patients using PROs for health management. Yet, communication around PROMs remains underexplored. Importantly, patients differ in their skills, knowledge, preferences, and motivations for completing PROMs, as well as in their ability and willingness to interpret and apply PROs in managing their health. Despite this, current communication practices often fail to account for these differences. This paper highlights the importance of personalized communication to make PROMs accessible to diverse populations. Personalizing communication manually is highly labor-intensive, but several digital technologies can offer a feasible solution to accommodate various patients. Despite their potential, these technologies have not yet been applied to PROMs. We explore how existing principles and tools, such as automatic data-to-text generation (including multimodal outputs like text combined with data visualizations) and conversational agents, can enable personalized communication of PROMs in practice.

Purpose Introduce and explore issues at an international conference about the use of patient-reported outcomes (PROs) in clinical practice. Methods Review of salient literature, clinical and personal experiences, conference presentations and discussions, and post-conference comments from outside experts. Results PROs (information from patients about a health condition and its management) have been assessed through self-reports for at least four decades. Traditional applications are in clinical and health services research. Uses in clinical practice, although increasing, are less common and more challenging. PROs can enhance the understanding of patients' experiences and responses to therapy and inform clinical practice. Conclusions We pose and discuss four main questions: (1) Will clinicians accept PRO measures? (2) Will clinicians use PRO measures? (3) Will measuring PROs actually improve those outcomes? (4) Will PROs be perceived as having other, less salutary purposes? A patientcentered perspective on PRO measurement presents issues about the extent to which PROs can accurately capture patient experiences and assess psychosocial and environmental factors that influence communication with clinicians and eventual outcomes. We end with comments about the intersection of PROs and bioethics, noting contributions that PROs may make to beneficence, patient autonomy, and distributive justice.

To develop a new multidimensional oral health indicator (MOHi) to ascertain and characterize overall oral health status. MOHi was developed using data from first-time patients (  = 1,034) attending a university dental clinic over an 18-month period. Participants completed the Oral Health Value Scale (OHVS), the Oral Health Impact Profile-14 (OHIP-14) and self-reported periodontal status questionnaires. Caries experience through Decayed, Missing and Filled Teeth (DMFT) index, was combined with radiographs. MOHi was built as a linear combination of the normalized OHVS, OHIP-14 and DMFT scores, in a continuous scale from 0 to 3, with higher scores representing a more degraded oral health condition. MOHi was evaluated according to sociodemographic, behavioral characteristics, and periodontal self-reported status. We compared MOHi mean values with t- Student's test and ANOVA one-way. Stepwise multivariate logistic regression methodologies modelled MOHi and identified significant predictors. Model performance was evaluated by ROC/AUC analysis. MOHi had a normal distribution adequacy (ranging 0.29-2.47), with an average of 1.22 (±0.41). Significantly higher MOHi scores were found in patients with self-reported periodontitis (  < 0.001), former/active smokers (  < 0.001), elementary/middle education level (  < 0.001), employed/retired (  < 0.001), age >= 45 years (  < 0.001) and married/divorced/widowed (  < 0.001). The final reduced logistic regression model identified age (OR = 1.05), self-reported periodontitis (OR = 1.94), sex-female (OR = 1.80), smoking status active/former (OR = 3.12/OR = 1.62), education level-elementary/middle (OR = 2.94/OR = 2.27) as predictor conditions towards a more degraded oral health condition (AUC = 0.81). MOHi has shown to be a promising tool to comprehensively characterize the overall oral health status.

The assessment and treatment of chronic pain rely heavily on patient self-report, making linguistically and culturally appropriate tools essential. However, no well-validated Arabic language measures of pain-related disability are widely available. The objective of this study was to create and validate a Modern Standard Arabic (MSA) version of the Pain Disability Index (PDI). This prospective cross-sectional study was conducted in a pain management clinic in a tertiary care center in the United Arab Emirates (UAE). The MSA PDI was developed using a forward–backward translation protocol by a team of native Arabic speakers from diverse backgrounds, reviewed by a professional translation company, and pilot-tested with a small sample of patients. Participants completed the MSA PDI along with measures of depression (PHQ-8), anxiety (GAD-7), and current pain severity. A total of 423 Arabic-speaking adults participated (54.84%) women, mean age of 43.71 ± 13.53, most of whom were UAE nationals (88.41%). The mean PDI score was 31.29 (±17.64), indicating moderate pain-related disability. Over half of the sample met screening thresholds for moderate to severe pain (50.83%), depression (57.21%), or anxiety (38.77%). Factor analysis of the MSA PDI supported a unidimensional structure. The MSA PDI also demonstrated excellent internal consistency (α = .91). Construct validity was supported through a tiered multi-method approach (correlation, regression, and structural equation modeling), which showed moderate positive associations between pain severity, depression, anxiety, and pain-related disability. Overall, the MSA PDI showed strong psychometric properties and provides a reliable, standardized tool for assessing pain-related disability in Arabic-speaking populations.

Background Researchers often rely on trial participants to self-report clinical outcomes (for example, fractures, re-operations). Little information exists as to the ‘accuracy’ of participant-reported clinical outcomes, particularly in randomised controlled trials (RCTs). To help address this evidence gap, we report four case studies, nested within different RCTs where participant-reported clinical outcome data were compared with those reported by clinicians or extracted from medical notes. Methods Four publicly-funded RCTs with different methods of verifying participant-reported outcomes were identified. In KAT, the participants were asked about hospital admissions for any reason. Where it was thought to be relevant to the trial knee, further information was sought from the lead surgeon at the admitting site to confirm whether or not the admission was relevant to the trial knee. In REFLUX, participants were asked about hospital admissions for any reason. For participants who reported a re-operation, further information was sought from the lead surgeon at the admitting site to confirm this. In RECORD, participants were asked three questions regarding broken bones. Where low-trauma fractures were reported, clinical verification was sought, initially from the research nurse at the site. In CATHETER, participants were asked about urinary tract infections (UTIs), and a prescription of antibiotics was provided for the treatment of UTIs following urethral catheterisation. The GPs of those who reported a UTI were contacted to confirm that an antibiotic prescription had been issued for the suspected UTI. Results In KAT, 397 of 6882 (6%) participant-reported hospital admissions were confirmed as relevant to the trial knee. In REFLUX, 16 of 19 participants (84%) who appeared to have had a re-operation were confirmed as having had one. In RECORD, 473 of 781 (61%) fractures reported by participants were confirmed as being low-trauma fractures. In CATHETER, 429 of 830 participant-reported UTIs (52%) were confirmed as such by the GPs. Conclusions We used different approaches in our verification of participant-reported outcomes in clinical trials, and we believe there is no one optimal solution. Consideration of issues such as what information is sought from participants, the phrasing of questions, whether the medical records are a true ‘gold standard’ and costs and benefits to the RCT may help determine the appropriate approach.

Objective: This systematic review and meta-analysis compared the patient-reported outcomes of intra-articular facet joint injections of normal saline and selected active substances to identify a more effective agent for treating subacute and chronic low back pain (LBP). Methods: The PubMed, Embase, Scopus, Web of Science, and CENTRAL databases were searched for randomized controlled trials and observational studies published in English. A research quality assessment was performed using ROB2 and ROBINS-I. A meta-analysis was conducted using a random-effects model, and the mean differences (MD) with 95% confidence intervals (CI) in efficacy outcomes, including pain, numbness, disability, and quality of life, were assessed. Results: Of the 2467 potential studies, 3 were included (247 patients). The active substances and normal saline had similar therapeutic effects on pain within 1 h, after 1–1.5 months, and after 3–6 months, with MD and 95% CI of 2.43 and −11.61 to 16.50, −0.63 and −7.97 to 6.72, and 1.90 and −16.03 to 19.83, respectively, as well as on the quality of life after 1 and 6 months. Conclusions: The short- and long-term clinical effects of intra-articular facet joint injections of normal saline are comparable to those of other active substances in patients with LBP.

Purpose Interest in collecting patient-reported outcomes (PROs), such as health-related quality of life (HRQOL), health status reports, and patient satisfaction is on the rise and practical aspects of collecting PROs in clinical practice are becoming more important. The purpose of this paper is to draw the attention to a number of issues relevant for a successful integration of PRO measures into the daily work flow of busy clinical settings. Methods The paper summarizes the results from a breakout session held at an ISOQOL special topic conference for PRO measures in clinical practice in 2007. Results Different methodologies of collecting PROs are discussed, and the support needed for each methodology is highlighted. The discussion is illustrated by practical reallife examples from early adaptors who administered paperpencil, or electronic PRO assessments (ePRO) for more than a decade. The paper also reports about new experiences with more recent technological developments, such as SmartPens and Computer Adaptive Tests (CATs) in daily practice. Conclusions Methodological and logistical issues determine the resources needed for a successful integration of PRO measures into daily work flow procedures and influence significantly the usefulness of PRO data for clinical practice.

Background Patient-reported measures include preferences and reports about care received, health behaviors, and outcomes of care (patient satisfaction and healthrelated quality of life). These measures are a core aspect of health care, but there is much to be learned about how to use them to improve clinical practice. Method We specify linkages among different patient-reported measures and focus upon the prospects and challenges for use of patient-reported outcomes in clinical practice. Results Patient-reported measures are important throughout the continuum of patient care. At the initial visit, patientreported outcomes provide information about what is important to the patient, the patient's current behaviors, and the patient's baseline health-related quality of life. At subsequent visits, patient-reported outcomes help evaluate disease progression or regression as well as treatment effects. Conclusions Patient-reported measures can help clinicians target interventions that will improve patient outcomes of care. However, there are a number of challenges in using patient-reported outcomes in clinical practice.